Knee OsteoarthritisCPWNCT04620525
Cognition, Pain and Wellbeing
An observational study of Knee Osteoarthritis and Knee Pain Chronic, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Osteoarthritis (OA) is the most common form of arthritis and for 4 in 10 people pain from OA is not adequately controlled. The pain experience of people suffering from chronic pain largely depends on their individual perception of pain and on brain functions, in particular what is called "cognitive" functions. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis, Knee Pain Chronic, Knee Arthritis
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Nov 2019to 20 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited from previous studies undertaken by the Academic Rheumatology, University of Nottingham, who have expressed an interest in future research. Responders from the Investigating Musculoskeletal Health and Wellbeing cohort study (IMHWCS, n ~ 5,000) and Knee Pain and related health In the Community cohort study (KPIC, n ~ 3,000) will be sent an invitation letter and participant information sheet (PIS) with details about the Cognition, Pain and Wellbeing study. A telephone screening will be then done to confirm their eligibility for the study and their interest in participating and they will be booked an appointment for a single visit in Academic Rheumatology.
Who may be able to join
- Aged 40 years and onward
- Able to read and write English
- Have English as their first language
Who cannot join
- Persons who do not adequately understand verbal explanations of written information in English, or who have special communication needs or whose English is not their first language
- Dialysis patients or on home oxygen
- Terminal illness
- Serious mental illness
- Dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Link Between Cognitive Function and Chronic Pain: An Observational Cohort Study
Osteoarthritis (OA) is the most common form of arthritis and for 4 in 10 people pain from OA is not adequately controlled. The pain experience of people suffering from chronic pain largely depends on their individual perception of pain and on brain functions, in particular what is called "cognitive" functions. Cognitive functions include memory, attention, organisation and planning, task initiation, regulation of emotions and reflection of oneself and are important for everyday tasks, such as following a conversation or a story in a book or on TV, learning new things, remembering old and new information and making decisions. Good cognition predicts the risk of developing chronic pain after a painful event, such as surgery. Chronic pain patients report numerous cognitive impairments, with attention and memory being the two most prominent that can persist even after the original cause of pain has been treated. Little evidence exists regarding the nature and magnitude of these deficits and their underlying brain and psychological mechanisms in chronic knee OA. The investigators want to understand which cognitive functions and to what extent are associated with pain in patients with knee OA.
Read the detailed description
Osteoarthritis (OA) is the most common form of arthritis and for 4 in 10 people pain from OA is not adequately controlled. The pain experience of people suffering from chronic pain largely depends on their individual perception of pain and on brain functions, in particular what is called "cognitive" functions. Cognitive functions include memory, attention, organisation and planning, task initiation, regulation of emotions and reflection of oneself and are important for everyday tasks, such as following a conversation or a story in a book or on TV, learning new things, remembering old and new information and making decisions. Good cognition predicts the risk of developing chronic pain after a painful event, such as surgery. Chronic pain patients report numerous cognitive impairments, with attention and memory being the two most prominent that can persist even after the original cause of pain has been treated. Little evidence exists regarding the nature and magnitude of these deficits and their underlying brain and psychological mechanisms in chronic knee OA. The investigators want to understand which cognitive functions and to what extent are associated with pain in patients with knee OA. Identifying specific domains of cognitive function affected by chronic pain has a clinical utility; specific domains regulate certain aspects of activities of daily living, such as managing personal finances, grocery shopping, remembering to take medications and, thus, dealing with pain early in the disease course could prevent subsequent cognitive loss and long-term pain. To do this the investigators will examine the link between measures of pain and measures of cognition in people with knee OA. The investigators propose to measure knee pain, physical function, sleep quality and overall wellbeing with questionnaires and pain sensitivity measures. The investigators will measure cognition with questionnaires and computer-based tasks testing aspects of cognitive function, including memory and attention. The investigators will compare the questionnaire and pain sensitivity measures with questionnaire and measures of cognitive function in the same participants. The investigators will include tests of various aspects of a person's memory that will facilitate the establishment of which aspects are related to chronic pain. The investigators hypothesise that chronic pain is linked to specific cognitive deficits in patients with knee OA and managing pain, for example, with mild to moderate targeted exercise and healthy diet, may limit the risk of memory loss and dementia and, in turn, predict better treatment outcomes.
- Conditions
- Knee Osteoarthritis, Knee Pain Chronic, Knee Arthritis
- Keywords
- knee, osteoarthritis, pain
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with the relevant condition | Participants with the relevant condition | |
| Healthy controls | Healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain sensitivity measures
Quantitative sensory testing (QST) will be used to assess pain sensitivity with measures, such as pressure pain threshold (PPT). PPT is a valid measure of tenderness around the knee. QST is used to quantify pain perception and it is an objective measure of peripheral sensitisation (increased tenderness around the knee) and central sensitisation (increased pain perception in areas away from the knee). QST will be used to identify different pain phenotypes among participants and it will enable us to quantify peripheral and central sensitisation components of pain. Pain phenotypes will be then correlated to cognitive measures.
Measured: Conducted once, at assessment visit approximately 10 minutes
Pain sensitivity measures
Quantitative sensory testing (QST) will be used to assess pain sensitivity with measures, such as temporal summation (TS), TS is a measure of central sensitization. QST is used to quantify pain perception and it is an objective measure of peripheral sensitisation (increased tenderness around the knee) and central sensitisation (increased pain perception in areas away from the knee). QST will be used to identify different pain phenotypes among participants and it will enable us to quantify peripheral and central sensitisation components of pain. Pain phenotypes will be then correlated to cognitive measures.
Measured: Conducted once, at assessment visit approximately 4 minutes
Pain sensitivity measures
Quantitative sensory testing (QST) will be used to assess pain sensitivity with measures, such as conditioned pain modulation (CPM). CPM assesses the function of endogenous pain inhibitory pathways. QST is used to quantify pain perception and it is an objective measure of peripheral sensitisation (increased tenderness around the knee) and central sensitisation (increased pain perception in areas away from the knee). QST will be used to identify different pain phenotypes among participants and it will enable us to quantify peripheral and central sensitisation components of pain. Pain phenotypes will be then correlated to cognitive measures.
Measured: Conducted once, at assessment visit approximately 6 minutes
Pain severity measure
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), which is a self-administered 24 items questionnaire with three subscales assessing pain, stiffness and physical function, is an extensively utilised tool for the evaluation of hip and knee OA and will be used in the current study.
Measured: Conducted once, at assessment visit : approximately 5-10 minutes
Cognitive function
Cambridge Neuropsychological Test Automated Battery (CANTAB) (objective measure) including tests of prefrontal-dependent sustained visual attention (Rapid Visual Information Processing, RVP, 7 min), attentional set shifting (Intra-/ Extra- Dimensional Set Shift, IED, 7 min) and hippocampus-dependent paired associate learning (Visual Learning Paired Associates Learning, PAL, 8 min) will be used. Other CANTAB tests will be included for comparison (reaction time test, RTI, 3 min; Stroop-like test, MTT, 8 min; spatial working memory test, SWM, 4 min).
Measured: Conducted once, at assessment visit : approximately 40 minutes
Cognitive function
Questionnaire cognitive measures, including the Cognitive Failures Questionnaire (CFQ) will be used.
Measured: Conducted once, at assessment visit approximately 8 minutes
Cognitive function
Questionnaire cognitive measures including the Cognitive reflection test (CRT) will be used.
Measured: Conducted once, at assessment visit approximately 7 minutes
Neuropathic pain quality: PD-Q
The PainDETECT Questionnaire (PD-Q) is a self-report questionnaire developed to discriminate between nociceptive and neuropathic pain. It has been further modified (mPDQ) for use among specific pain groups, for example, knee pain. Neuropathic pain symptoms as identified with the mPDQ have been found to correlate with signs of central sensitisation in OA, as identified with QST.
Measured: Conducted once, at assessment visit : approximately 5-10 minutes
Secondary outcomes (10)
Premorbid IQ
The National Adult Reading Test (NART) will serve as a measure of general premorbid IQ.
Measured: Conducted once, at assessment visit approximately 10-15 minutes
Depression/Anxiety
The Hospital Anxiety and Depression Scale (HADS), a 14-item measure designed to assess anxiety and depression symptoms will be also used.
Measured: Conducted once, at assessment visit approximately 5-10 minutes
Sleep Quality: PSQI
Sleep disturbances are common within people experiencing chronic pain and are associated with impaired cognitive function both in males and females. For that reason, the Pittsburgh sleep quality index (PSQI) will be utilised to assess sleeping patterns in people with chronic pain.
Measured: Conducted once, at assessment visit approximately 5-10 minutes
Physical function
Functionality testing will be done using the 'time up and go' (TUG) test.
Measured: Conducted once, at assessment visit approximately 6 minutes
Physical function
Functionality testing will be done using the 30-second sit to stand test (30CST)
Measured: Conducted once, at assessment visit approximately 5 minutes
Altruism/Decision making
Participants will also complete a Dictator Game (DG) to explore the role of altruism in motivating subjects' behaviour in two independent settings, whereby participants will be given money (£10) and can donate some, all or none to: 1. an anonymous participant (75) and 2. a charity organisation.
Measured: Conducted once, at assessment visit approximately 5-10 minutes
Body mass index (BMI)
Clinical assessment of body weight and height to determine BMI.
Measured: Conducted once, at assessment visit approximately 5 minutes
Inflammatory biomarkers
Blood samples will be collected and serum sent for laboratory analysis to determine inflammatory biomarkers using RNA tubes.
Measured: Conducted once, at assessment visit approximately 5-15 minutes for blood collection.
biomarkers of insulin resistance
Urine samples will be collected and sent for laboratory analysis to determine biomarkers of insulin resistance
Measured: Once pre-assessment visit Urine sample will be collected at home and handed in at attendance of the visit 5 minutes
gut microbiome measures.
Faecal (optional) samples will be collected and sent for laboratory analysis to determine gut microbiome measures.
Measured: Once post-assessment visit Faecal samples will be done home and sent back in prepaid envelope. 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start7 Nov 2019
- Primary completion20 Mar 2020
- Study completion20 Mar 2020
Why it stopped: Covid-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Valdes, University of Nottingham
- Investigators
- Ana M Valdes, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620525
- Sponsor's protocol ID
- 1
- Acronym
- CPW
- Status last verified
- May 2024
- First submitted
- 22 Apr 2020
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Link Between Cognitive Function and Chronic Pain: An Observational Cohort Study
- ClinicalTrials.gov ID
- NCT04620525
- Acronym / sponsor ID
- CPW / 1
- Conditions
- Knee Osteoarthritis, Knee Pain Chronic, Knee Arthritis
- Keywords
- knee, osteoarthritis, pain
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Covid-19 pandemic
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 9 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Osteoarthritis (OA) is the most common form of arthritis and for 4 in 10 people pain from OA is not adequately controlled. The pain experience of people suffering from chronic pain largely depends on their individual perception of pain and on brain functions, in particular what is called "cognitive" functions. Cognitive functions include memory, attention, organisation and planning, task initiation, regulation of emotions and reflection of oneself and are important for everyday tasks, such as following a conversation or a story in a book or on TV, learning new things, remembering old and new information and making decisions. Good cognition predicts the risk of developing chronic pain after a painful event, such as surgery. Chronic pain patients report numerous cognitive impairments, with attention and memory being the two most prominent that can persist even after the original cause of pain has been treated. Little evidence exists regarding the nature and magnitude of these deficits and their underlying brain and psychological mechanisms in chronic knee OA. The investigators want to understand which cognitive functions and to what extent are associated with pain in patients with knee OA.
Detailed description
Osteoarthritis (OA) is the most common form of arthritis and for 4 in 10 people pain from OA is not adequately controlled. The pain experience of people suffering from chronic pain largely depends on their individual perception of pain and on brain functions, in particular what is called "cognitive" functions. Cognitive functions include memory, attention, organisation and planning, task initiation, regulation of emotions and reflection of oneself and are important for everyday tasks, such as following a conversation or a story in a book or on TV, learning new things, remembering old and new information and making decisions. Good cognition predicts the risk of developing chronic pain after a painful event, such as surgery. Chronic pain patients report numerous cognitive impairments, with attention and memory being the two most prominent that can persist even after the original cause of pain has been treated. Little evidence exists regarding the nature and magnitude of these deficits and their underlying brain and psychological mechanisms in chronic knee OA. The investigators want to understand which cognitive functions and to what extent are associated with pain in patients with knee OA. Identifying specific domains of cognitive function affected by chronic pain has a clinical utility; specific domains regulate certain aspects of activities of daily living, such as managing personal finances, grocery shopping, remembering to take medications and, thus, dealing with pain early in the disease course could prevent subsequent cognitive loss and long-term pain. To do this the investigators will examine the link between measures of pain and measures of cognition in people with knee OA. The investigators propose to measure knee pain, physical function, sleep quality and overall wellbeing with questionnaires and pain sensitivity measures. The investigators will measure cognition with questionnaires and computer-based tasks testing aspects of cognitive function, including memory and attention. The investigators will compare the questionnaire and pain sensitivity measures with questionnaire and measures of cognitive function in the same participants. The investigators will include tests of various aspects of a person's memory that will facilitate the establishment of which aspects are related to chronic pain. The investigators hypothesise that chronic pain is linked to specific cognitive deficits in patients with knee OA and managing pain, for example, with mild to moderate targeted exercise and healthy diet, may limit the risk of memory loss and dementia and, in turn, predict better treatment outcomes.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with the relevant condition | – | –Participants with the relevant condition |
| Healthy controls | – | –Healthy controls |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from previous studies undertaken by the Academic Rheumatology, University of Nottingham, who have expressed an interest in future research. Responders from the Investigating Musculoskeletal Health and Wellbeing cohort study (IMHWCS, n ~ 5,000) and Knee Pain and related health In the Community cohort study (KPIC, n ~ 3,000) will be sent an invitation letter and participant information sheet (PIS) with details about the Cognition, Pain and Wellbeing study. A telephone screening will be then done to confirm their eligibility for the study and their interest in participating and they will be booked an appointment for a single visit in Academic Rheumatology.
Key inclusion criteria (3 listed)
- Aged 40 years and onward
- Able to read and write English
- Have English as their first language
Key exclusion criteria (5 listed)
- Persons who do not adequately understand verbal explanations of written information in English, or who have special communication needs or whose English is not their first language
- Dialysis patients or on home oxygen
- Terminal illness
- Serious mental illness
- Dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain sensitivity measures
Time frame: Conducted once, at assessment visit approximately 10 minutes
Quantitative sensory testing (QST) will be used to assess pain sensitivity with measures, such as pressure pain threshold (PPT). PPT is a valid measure of tenderness around the knee. QST is used to quantify pain perception and it is an objective measure of peripheral sensitisation (increased tenderness around the knee) and central sensitisation (increased pain perception in areas away from the knee). QST will be used to identify different pain phenotypes among participants and it will enable us to quantify peripheral and central sensitisation components of pain. Pain phenotypes will be then correlated to cognitive measures.
Pain sensitivity measures
Time frame: Conducted once, at assessment visit approximately 4 minutes
Quantitative sensory testing (QST) will be used to assess pain sensitivity with measures, such as temporal summation (TS), TS is a measure of central sensitization. QST is used to quantify pain perception and it is an objective measure of peripheral sensitisation (increased tenderness around the knee) and central sensitisation (increased pain perception in areas away from the knee). QST will be used to identify different pain phenotypes among participants and it will enable us to quantify peripheral and central sensitisation components of pain. Pain phenotypes will be then correlated to cognitive measures.
Pain sensitivity measures
Time frame: Conducted once, at assessment visit approximately 6 minutes
Quantitative sensory testing (QST) will be used to assess pain sensitivity with measures, such as conditioned pain modulation (CPM). CPM assesses the function of endogenous pain inhibitory pathways. QST is used to quantify pain perception and it is an objective measure of peripheral sensitisation (increased tenderness around the knee) and central sensitisation (increased pain perception in areas away from the knee). QST will be used to identify different pain phenotypes among participants and it will enable us to quantify peripheral and central sensitisation components of pain. Pain phenotypes will be then correlated to cognitive measures.
Pain severity measure
Time frame: Conducted once, at assessment visit : approximately 5-10 minutes
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), which is a self-administered 24 items questionnaire with three subscales assessing pain, stiffness and physical function, is an extensively utilised tool for the evaluation of hip and knee OA and will be used in the current study.
Cognitive function
Time frame: Conducted once, at assessment visit : approximately 40 minutes
Cambridge Neuropsychological Test Automated Battery (CANTAB) (objective measure) including tests of prefrontal-dependent sustained visual attention (Rapid Visual Information Processing, RVP, 7 min), attentional set shifting (Intra-/ Extra- Dimensional Set Shift, IED, 7 min) and hippocampus-dependent paired associate learning (Visual Learning Paired Associates Learning, PAL, 8 min) will be used. Other CANTAB tests will be included for comparison (reaction time test, RTI, 3 min; Stroop-like test, MTT, 8 min; spatial working memory test, SWM, 4 min).
Cognitive function
Time frame: Conducted once, at assessment visit approximately 8 minutes
Questionnaire cognitive measures, including the Cognitive Failures Questionnaire (CFQ) will be used.
Cognitive function
Time frame: Conducted once, at assessment visit approximately 7 minutes
Questionnaire cognitive measures including the Cognitive reflection test (CRT) will be used.
Neuropathic pain quality: PD-Q
Time frame: Conducted once, at assessment visit : approximately 5-10 minutes
The PainDETECT Questionnaire (PD-Q) is a self-report questionnaire developed to discriminate between nociceptive and neuropathic pain. It has been further modified (mPDQ) for use among specific pain groups, for example, knee pain. Neuropathic pain symptoms as identified with the mPDQ have been found to correlate with signs of central sensitisation in OA, as identified with QST.
10 secondary outcomes
Premorbid IQ
Time frame: Conducted once, at assessment visit approximately 10-15 minutes
Depression/Anxiety
Time frame: Conducted once, at assessment visit approximately 5-10 minutes
Sleep Quality: PSQI
Time frame: Conducted once, at assessment visit approximately 5-10 minutes
Physical function
Time frame: Conducted once, at assessment visit approximately 6 minutes
Physical function
Time frame: Conducted once, at assessment visit approximately 5 minutes
Altruism/Decision making
Time frame: Conducted once, at assessment visit approximately 5-10 minutes
Body mass index (BMI)
Time frame: Conducted once, at assessment visit approximately 5 minutes
Inflammatory biomarkers
Time frame: Conducted once, at assessment visit approximately 5-15 minutes for blood collection.
biomarkers of insulin resistance
Time frame: Once pre-assessment visit Urine sample will be collected at home and handed in at attendance of the visit 5 minutes
gut microbiome measures.
Time frame: Once post-assessment visit Faecal samples will be done home and sent back in prepaid envelope. 15 minutes
Results and safety
The study was stopped early (reason given: Covid-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana M Valdes, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis and Knee Pain Chronic, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Covid-19 pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain sensitivity measures (time frame: Conducted once, at assessment visit approximately 10 minutes). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.